MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES REAL INTELLIGENCE CORI; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number ROB10024

Device Problem Application Program Freezes, Becomes Nonfunctional (4031)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/14/2022

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference: case: (b)(4).

Event Description

It was reported that, on calibration of the real intelligence robotic drill in a cori assisted ukr surgery, they received a "robotic drill has been deactivated" error as soon they plugged the connector into the console.They pushed continue to reinitialize the robotic drill and the confirmation green tick on the monitor flickered rapidly and the screen froze.They had to shut the case down and resume the case to continue.The procedure was finished with a smith and nephew back up device with a 5 minute delay.The patient was not harmed.Additionally, after the case, they performed a robotics drill diagnostic test and a robotic drill critical error popped up as soon as they push the start button to initiate the test.When pushing the continue button, a "robotic drill internal error has occured" was displayed.They check the robotic drill and push continue to try again.Also, the ri robotic drill attachment and the real intelligence robotic drill tracker are lock on the drill.

Manufacturer Narrative

H3, h6: the real intelligence cori, part number rob10024, serial number (b)(6), intended for use in treatment, was returned for evaluation.The reported problem could not be confirmed with a visual or functional inspection as the console was not returned.A video and pictures of the event were provided and confirm the drill disconnect and flicker.The log files were reviewed and the reported drill disconnect error was confirmed.A relationship between the reported event and the device could not be established.The most likely cause of this event is a faulty exposure motor connection in the drill used for the case.No issues appear to be associated with the cori system itself.A review of manufacturing records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints has identified prior events.The failure mode and associated risk have been anticipated within the risk file.The risk level is still adequate.Based on the investigation, the need for a corrective action is not recommended or required at this time.Should any additional information be received the complaint will be reopened.The failure mode will continue to be closely monitored through complaint investigation and trended through post market surveillance activities.

• Brand Name: REAL INTELLIGENCE CORI
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• Manufacturer (Section G): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 13664264
• MDR Text Key: 286925042
• Report Number: 3010266064-2022-00164
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556757420
• UDI-Public: 00885556757420
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K193120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROB10024
• Device Catalogue Number: ROB10024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/23/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1